The U.S. Food and Drug Administration (FDA) is requiring new safety warnings for glucagon-like peptide-1 (GLP-1) medications over a potential increased risk of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition that can cause sudden, painless vision loss.
The decision applies to the entire drug class, including medications used to manage diabetes and obesity such as Ozempic, Wegovy, Mounjaro, and Zepbound. Manufacturers must add the potential risk to the Warnings and Precautions sections of their labels.
Evidence and Guidance
The FDA reviewed clinical trials, observational studies, and postmarketing reports. Its analysis of 126 randomized controlled trials involving more than 134,000 patients identified 6.4 NAION cases per 100,000 person-years among GLP-1 users, compared with 3.8 among patients receiving a placebo or another glucose-lowering medication.
The agency’s investigation followed a 2024 JAMA Ophthalmology study reporting an association between semaglutide prescriptions and NAION. However, researchers cautioned that the findings did not establish causation.
The FDA advises patients experiencing sudden vision loss, blind spots, or other abrupt visual changes to contact a health care professional immediately. The agency also recommends clinicians promptly refer suspected NAION cases to an ophthalmologist and weigh the benefits and risks of continued GLP-1 treatment if NAION develops, unless the treatment benefits clearly outweigh the risk.
AOA Response
Following the FDA announcement, the American Optometric Association (AOA) issued a statement emphasizing proactive eye care for patients taking GLP-1 medications. In the statement, the AOA said its priority remains helping patients benefit from these treatments while protecting their sight.
“GLP-1 medications offer significant health benefits, and the potential for rare vision complications should not cause unnecessary alarm,” the AOA says. “Rather, the FDA’s action reinforces the importance of the proactive approach the AOA has advocated, including a baseline, in-person comprehensive eye examination and appropriate follow-up care with a doctor of optometry.”